Promotion and Prescribing of Hormone Therapy After Report of Harm by the Women’s Health Initiative

Abstract

ContextLittle is known about how the pharmaceutical industry responds to evidence of harm associated with its products, such as the publication in July 2002 of the Women's Health Initiative Estrogen Plus Progestin Trial (WHI E+P) report demonstrating that standard-dose Prempro produced significant harm and lacked net benefits.Objective To examine pharmaceutical industry response to the WHI E+P results by analyzing promotional expenditures for hormone therapy before and after July 2002. Design and SettingNationally representative and prospectively collected longitudinal data (January 2001 through December 2003) on prescribing and promotion of hormone therapies were obtained from IMS Health and Consumer Media Reports.

Failure to Adopt Beneficial Therapies Caused by Bias in Medical Evidence Evaluation

“…The experimental design employed allowed us to control the distinction between harmful and beneficial therapies as an independent variable, thereby eliminating confounding from other factors. This bias is consistent with others' observations that harmful therapies appear to be abandoned relatively quickly 12,14,19,20 and may be relevant to understanding the research-practice gap in terms of underutilization of beneficial therapies.…”

Long-Term Effect of the Women's Health Initiative Study on Antiosteoporosis Medication Prescribing

“…Our findings on patterns of AOM prevalence after the WHI publication were similar to those in the published literature, [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] indicating that the prevalence of estrogen use declined by 29%-69% and bisphosphonate use increased by about 18%. Our study found a similar decrease in the prevalence of visits associated with estrogen prescription (46% reduction), but in contrast to those studies, we found a more than 2-fold increase in bisphosphonate-related visits after the WHI publication.…”

Menopausal Hormone Therapy and Risk of Epithelial Ovarian Cancer

“…However, cases and controls were unaware of the hypotheses of this study, and among cases, the large majority of refusals were among women who were too ill to be interviewed. Also, during the course of the study, we observed reductions in HT use that were of similar magnitude among cases and controls and consistent with national trends (17,19). For example, among controls with reference dates in 2002, 56% of women who had ever taken EPT were currently using the drug, whereas in 2005, the corresponding figure was 27%.…”